Biosafety Engineer

Qualifications & Experience

Responsibilities

• Within the Medical Business Unit, you are part of the team of specialists who ensure the biocompatibility of our medical devices and develop and validate their cleaning, packaging and sterilization processes.
• You participate in medical device development by supporting biological safety evaluations in accordance with ISO 10993-1 and by executing cleaning and sterilization process validations. In addition, you develop new or optimized packaging for sterile and non-sterile medical devices and test their performance. You set up and take part in monitoring programs to ensure continued fulfillment of requirements. You contribute to regulatory submissions of new devices.
• You build a thorough understanding of the manufacturing process, especially the steps related to cleaning, packaging, and sterilization, to effectively plan new development and validation activities. You create and finalize validation protocols and reports ensuring they are clear, concise and compliant to work instructions and standards. You assess the impact of the process or product changes and propose adequate actions. You plan and follow-up test sample production with the manufacturing team and with suppliers. You coordinate the tests that are being performed at external test labs.
• You interact closely with internal stakeholders (including the Quality, Development, Process Engineering, and Manufacturing teams) and external partners (including test labs and suppliers) to ensure good communication and swift collaboration.
• You act as an ambassador and safeguard of biological safety within Materialise Medical.

Requirements

• Master degree (engineering, biochemistry, biology or medical) with at least 3 years of medical device industry experience
• Knowledge and understanding of regulatory requirements, standards, and guidance documents in the field of biocompatibility evaluation, cleaning validation, packaging development or sterilization validation of medical devices
• Able to work on multiple projects simultaneously, set priorities, and establish short and long-term planning horizons
• Effective as a team member to accomplish project deadlines and objectives, yet able to work and make decisions independently to reach goals
• Clear and effective verbal communication and technical writing skills in English
• Good analytical skills, meticulous approach with a high level of attention to detail
• Passionate about patient safety and customer satisfaction